Regulations for Good Clinical Practice Article 91
The investigator, or person designated by the investigator, should document and explain any deviation from the protocol.
中文原文 藥品優良臨床試驗作業準則第91條
試驗主持人或經其指定之人員，應記錄及解釋執行試驗計畫書之偏差。
English translation for reference only; the Chinese text prevails. Not legal advice.